Avadel Pharmaceuticals Announces Publication in Clinical Therapeutics of Data Highlighting Weight Loss in People with Narcolepsy Treated with LUMRYZ™ (sodium oxybate) Extended-Release Oral Suspension
Avadel Pharmaceuticals (AVDL) has published results from a post-hoc analysis of their Phase 3 REST-ON clinical trial for LUMRYZ, a once-nightly sodium oxybate treatment for narcolepsy. The study, published in Clinical Therapeutics, showed that LUMRYZ use was associated with weight loss in narcolepsy patients.
Key findings include:
- LUMRYZ-treated participants lost a mean of 1.3 kg over 13 weeks, while placebo group gained 0.2 kg
- 17.8% of LUMRYZ group experienced ≥5% weight loss vs 3.8% in placebo group
- Significant BMI reduction observed in LUMRYZ group compared to placebo
- Weight loss group showed improvements in narcolepsy symptoms
These results suggest LUMRYZ may offer a tailored treatment approach for narcolepsy patients who are overweight or obese, addressing both core symptoms and weight management.
Avadel Pharmaceuticals (AVDL) ha pubblicato i risultati di un'analisi post-hoc del loro studio clinico di Fase 3 REST-ON per LUMRYZ, un trattamento a base di sodio ossibato assunto una volta a notte per la narcolessia. Lo studio, pubblicato su Clinical Therapeutics, ha mostrato che l'uso di LUMRYZ era associato a una perdita di peso nei pazienti affetti da narcolessia.
I risultati principali includono:
- I partecipanti trattati con LUMRYZ hanno perso in media 1,3 kg in 13 settimane, mentre il gruppo placebo ha guadagnato 0,2 kg
- Il 17,8% del gruppo LUMRYZ ha sperimentato una perdita di peso ≥5%, rispetto al 3,8% nel gruppo placebo
- Una significativa riduzione dell'IMC è stata osservata nel gruppo LUMRYZ rispetto al placebo
- Il gruppo con perdita di peso ha mostrato miglioramenti nei sintomi legati alla narcolessia
Questi risultati suggeriscono che LUMRYZ potrebbe offrire un approccio terapeutico personalizzato per i pazienti affetti da narcolessia in sovrappeso o obesi, affrontando sia i sintomi fondamentali che la gestione del peso.
Avadel Pharmaceuticals (AVDL) ha publicado los resultados de un análisis post-hoc de su ensayo clínico de Fase 3 REST-ON para LUMRYZ, un tratamiento de oxibato de sodio tomado una vez por noche para la narcolepsia. El estudio, publicado en Clinical Therapeutics, mostró que el uso de LUMRYZ estaba asociado con la pérdida de peso en pacientes con narcolepsia.
Los hallazgos clave incluyen:
- Los participantes tratados con LUMRYZ perdieron un promedio de 1.3 kg en 13 semanas, mientras que el grupo placebo ganó 0.2 kg
- El 17.8% del grupo LUMRYZ experimentó una pérdida de peso ≥5% frente al 3.8% en el grupo placebo
- Se observó una reducción significativa del IMC en el grupo LUMRYZ en comparación con el placebo
- El grupo con pérdida de peso mostró mejoras en los síntomas de la narcolepsia
Estos resultados sugieren que LUMRYZ podría ofrecer un enfoque de tratamiento personalizado para pacientes con narcolepsia que son sobrepeso u obesos, abordando tanto los síntomas centrales como la gestión del peso.
Avadel Pharmaceuticals (AVDL)는 LUMRYZ에 대한 3상 REST-ON 임상 시험의 후속 분석 결과를 발표했습니다. LUMRYZ는 기면증 치료를 위한 나트륨 옥시베이트로, 매일 밤 한 번 복용합니다. Clinical Therapeutics에 발표된 이 연구는 LUMRYZ의 사용이 기면증 환자에서 체중 감소와 관련이 있음을 보여주었습니다.
주요 결과는 다음과 같습니다:
- LUMRYZ 치료를 받은 참가자는 13주 동안 평균 1.3kg을 잃었으며, 반면 위약 그룹은 0.2kg 증가하였습니다.
- LUMRYZ 그룹의 17.8%가 ≥5%의 체중 감소를 경험했으며, 위약 그룹은 3.8%였습니다.
- 위약 대비 LUMRYZ 그룹에서 BMI의 유의미한 감소가 관찰되었습니다.
- 체중 감소 그룹은 기면증 증상 개선을 보였습니다.
이 결과는 LUMRYZ가 과체중 또는 비만인 기면증 환자에게 맞춤형 치료 접근을 제공할 수 있음을 시사하며, 주요 증상과 체중 관리를 모두 다루고 있습니다.
Avadel Pharmaceuticals (AVDL) a publié les résultats d'une analyse post-hoc de son essai clinique de Phase 3 REST-ON pour LUMRYZ, un traitement à base d'oxybate de sodium pris une fois par nuit pour la narcolepsie. L'étude, publiée dans Clinical Therapeutics, a montré que l'utilisation de LUMRYZ était associée à une perte de poids chez les patients narcoleptiques.
Les principaux résultats comprennent :
- Les participants traités avec LUMRYZ ont perdu en moyenne 1,3 kg en 13 semaines, tandis que le groupe placebo a gagné 0,2 kg
- 17,8 % du groupe LUMRYZ ont présenté une perte de poids ≥5 % contre 3,8 % dans le groupe placebo
- Une réduction significative de l'IMC a été observée dans le groupe LUMRYZ par rapport au placebo
- Le groupe ayant perdu du poids a montré des améliorations des symptômes de la narcolepsie
Ces résultats suggèrent que LUMRYZ pourrait offrir une approche de traitement personnalisée pour les patients narcoleptiques en surpoids ou obèses, s'attaquant à la fois aux symptômes fondamentaux et à la gestion du poids.
Avadel Pharmaceuticals (AVDL) hat die Ergebnisse einer post-hoc Analyse ihrer Phase-3-REST-ON-Studie für LUMRYZ veröffentlicht, ein einmal nächtlich anzuwendendes Natrium-Oxybat-Präparat zur Behandlung von Narkolepsie. Die Studie, veröffentlicht in Clinical Therapeutics, zeigte, dass die Anwendung von LUMRYZ mit Gewichtsverlust bei Patienten mit Narkolepsie verbunden war.
Wesentliche Ergebnisse umfassen:
- Teilnehmer, die mit LUMRYZ behandelt wurden, verloren im Durchschnitt 1.3 kg über 13 Wochen, während die Placebogruppe 0.2 kg zunahm
- 17.8% der LUMRYZ-Gruppe erlebten einen ≥5%igen Gewichtsverlust im Vergleich zu 3.8% in der Placebogruppe
- Eine signifikante Reduktion des BMI wurde in der LUMRYZ-Gruppe im Vergleich zur Placebo-Gruppe beobachtet
- Die Gewichtsverlustgruppe zeigte Verbesserungen in den Narkolepsie-Symptomen
Diese Ergebnisse deuten darauf hin, dass LUMRYZ einen maßgeschneiderten Behandlungsansatz für übergewichtige oder adipöse Narkolepsie-Patienten bieten könnte, der sowohl die Kernsymptome als auch das Gewichtmanagement anspricht.
- LUMRYZ demonstrated efficacy in reducing weight and BMI in narcolepsy patients
- 17.8% of LUMRYZ-treated participants experienced clinically meaningful weight loss (≥5%)
- LUMRYZ showed improvement in core narcolepsy symptoms (excessive daytime sleepiness and cataplexy)
- Publication in Clinical Therapeutics may increase credibility and visibility of LUMRYZ's benefits
- None.
This publication of post-hoc analysis from the REST-ON clinical trial reveals significant weight loss benefits associated with LUMRYZ treatment for narcolepsy patients. Key findings include:
- LUMRYZ group lost a mean of
1.3 kg vs0.2 kg gain in placebo group 17.8% of LUMRYZ patients achieved ≥5% weight loss vs3.8% in placebo (p=0.001)- Significant BMI reduction: -0.59 kg/m2 difference vs placebo (p=0.001)
These results are particularly relevant given the high prevalence of obesity in narcolepsy patients (
While I primarily focus on cancer treatments, the weight loss findings in this narcolepsy study are intriguing from a broader health perspective. Obesity is a significant risk factor for various cancers and cardiovascular diseases. The fact that LUMRYZ demonstrated both narcolepsy symptom improvement and weight loss is noteworthy.
The shift from obese to overweight and from overweight to normal weight categories, without any participants becoming underweight, suggests a safe and controlled weight loss profile. This could have positive implications for overall health outcomes in narcolepsy patients, potentially reducing their risk of obesity-related comorbidities, including certain cancers.
From a market perspective, these findings could significantly boost LUMRYZ's competitive position. The dual benefit of narcolepsy symptom control and weight loss addresses two major health concerns simultaneously, potentially expanding its market appeal. With obesity rates high in the U.S., a narcolepsy treatment offering weight loss benefits could capture a larger market share.
Moreover, the once-at-bedtime dosing of LUMRYZ provides a unique selling point, offering improved sleep quality - a important factor for both narcolepsy management and weight control. This combination of benefits and convenience could drive patient preference and physician recommendations, potentially leading to increased adoption and sales for Avadel Pharmaceuticals.
DUBLIN, Aug. 20, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial demonstrating greater weight loss in patients who received LUMRYZ compared with placebo. The paper, titled “Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial,” was published online in Clinical Therapeutics.
“Obesity is a struggle for many people, and it is very common in patients with narcolepsy,” said Asim Roy, M.D., co-author of the paper and Medical Director of the Ohio Sleep Medicine Institute. “Obesity is an important modifiable risk factor for cardiovascular diseases. These new data show that LUMRYZ use was associated with a reduction in body mass index and weight during the 13-week trial. While all REST-ON participants, including both narcolepsy Type 1 (with cataplexy) and narcolepsy Type 2 (without cataplexy) showed improvement in core narcolepsy symptoms (i.e., excessive daytime sleepiness and cataplexy), this improvement was even more pronounced in the subgroup experiencing a ≥
REST-ON is a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial evaluating once-at-bedtime LUMRYZ in adults with narcolepsy. Weight and body mass index (BMI) were measured at baseline and at the end of the study. The mean age of the study participants was 31.2 years,
“Given the high rates of obesity in the U.S, and its associated cardiometabolic risks, we were encouraged to see that nearly one in five study participants treated with LUMRYZ experienced clinically meaningful weight loss,” said Jennifer Gudeman, Pharm.D., Senior Vice President, Medical and Clinical Affairs of Avadel. “These findings suggest that LUMRYZ, given its proven benefit in reducing cataplexy and EDS, as well its once-at-bedtime dosing, which provides the opportunity for an uninterrupted night sleep, has the potential to provide a more tailored treatment approach for people with narcolepsy who are overweight or living with obesity.”
Results of the post-hoc analysis, which evaluated the effect of LUMRYZ treatment on weight in adults with narcolepsy and further characterized participants experiencing >
- Participants who received LUMRYZ lost a mean of 1.3 kg from baseline to week 13. In contrast, those receiving placebo experienced a mean weight gain of 0.2 kg.
- A significantly higher proportion of study participants receiving LUMRYZ experienced ≥
5% weight loss than those who received placebo (17.8% versus3.8% ; p=0.001). - A significant reduction in BMI was observed after 13 weeks of treatment with LUMRYZ versus placebo, with a between-group difference in least squares mean change from baseline of −0.59 kg/m2 (p=0.001).
- In the weight loss group, participants shifted from obese into overweight, and from overweight into normal weight during this trial; no participants were underweight.
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
IMPORTANT SAFETY INFORMATION
| WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death. The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects. Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. |
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in adults with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
It is not known if LUMRYZ is safe and effective in people less than 18 years of age.
Do not take LUMRYZ if you take other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the following:
- Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
- Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you have or had depression or have tried to harm yourself. Call your doctor right away if you have symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking.
Tell your doctor if you are on a salt-restricted diet or if you have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED Warning.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ™, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. For more information, please visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the potential therapeutic benefit of LUMRYZ in treating narcolepsy-related EDS or cataplexy, including potential impact on patient weight; and the results and analysis of the Phase 3 REST-ON trial, including the details and content thereof. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable).
The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Investor Contact:
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FAQ
What were the main findings of Avadel's LUMRYZ study published in Clinical Therapeutics?
How does LUMRYZ (AVDL) potentially benefit overweight or obese narcolepsy patients?
What percentage of narcolepsy patients in the LUMRYZ (AVDL) study were overweight or obese at baseline?
How does LUMRYZ's (AVDL) once-at-bedtime dosing potentially benefit narcolepsy patients?
